The following data is part of a premarket notification filed by Optics Laboratory, Inc. with the FDA for Lensgiene Sterile Saline Solution.
| Device ID | K161622 |
| 510k Number | K161622 |
| Device Name: | LensGiene Sterile Saline Solution |
| Classification | Accessories, Soft Lens Products |
| Applicant | Optics Laboratory, Inc. 9480 Telstar Ave Suite 3 El Monte, CA 91731 -2988 |
| Contact | Patricia Chiu |
| Correspondent | Paul Kramsky Rockin' Regulatory, Inc. 21831 Tumbleweed Circle Lake Forest, CA 92630 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-13 |
| Decision Date | 2016-08-11 |
| Summary: | summary |